Four-Factor Prothrombin Complex Concentrate Reduces Time to Procedure in Vitamin K Antagonist-Treated Patients Experiencing Gastrointestinal Bleeding: A Post Hoc Analysis of Two Randomized Controlled Trials

Table 4

Efficacy endpoints from the original phase IIIb studies.

	4F-PCC ()	Plasma ()	value
Primary endpoint
Hemostatic efficacy, (%)
Excellent	12 (55)	11 (55)	0.98
Good	4 (18)	4 (20)
Poor/none	6 (27)	5 (2.05)
Coprimary endpoint; Rapid INR reduction, (%)	13 (65)	0	<0.0001
Secondary endpoint: time from start of infusion to INR reduction ≤1.3, hours, mean (SD)	2.6 (5.5)	14.3 (8.8)	0.0001

In both studies, hemostatic efficacy was assessed by an independent Endpoint Adjudication Board: over a 24-hour period from the start of infusion (bleeding study) or from the start of infusion to the end of procedure (surgery study), as excellent, good, or poor/none. (Surgery study hemostatic efficacy was originally reported as a binary endpoint [effective or noneffective] as assessed from the start of infusion to the end of the procedure, and effective hemostasis was defined as intraoperative blood loss not exceeding predicted blood loss by 30% or 50 mL, normal or mildly abnormal hemostasis [surgeon assessed], and no administration of nonstudy coagulation products). 1.3 at 30 min after end of infusion. 4F-PCC, 4-factor prothrombin complex concentrate; INR, international normalized ratio; min, minutes; SD, standard deviation.